BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC 40 REFOBACIN PLUS BONE CEMENT

    MDR report key: 10222702 · Received July 2, 2020

    Report

    Report Number
    3006946279-2020-00122
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 5, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. A RETAIN SAMPLE OF BATCH A945A06220 HAS BEEN TESTED IN THE LABORATORY UNDER STANDARDIZED CONDITIONS (23°C; REL. HUMID >=40 %). NO UNUSUAL BEHAVIOR DURING MIXING, HANDLING OR SETTING. THE REPORTED BEHAVIOR OF THE CEMENT CANNOT BE REPRODUCED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A COMPLAINT EXTRACT WAS DONE REGARDING CEMENT PASTE TOO SHORT SETTING TIME: 5 COMPLAINTS (7 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-3, REFERENCE (B)(4), FROM (B)(6) 2017 TO (B)(6) 2020. 2 COMPLAINTS (2 PRODUCTS), THIS ONE INCLUDED, HAVE BEEN RECORDED ON OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-3, REFERENCE (B)(4), BATCH A945A06220. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. HOWEVER, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO THE PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BONE CEMENT OF THE OPTIPAC HARDENED TOO QUICKLY. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED AS THE RESULT OFTHE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BONE CEMENT OF THE OPTIPAC HARDENED TOO QUICKLY. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED AS THE RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686561 OPTIPAC 40 REFOBACIN PLUS BONE CEMENT BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. A945A06220

    Patients

    Seq Age Sex Outcome Treatment
    1